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Laboratory equipment and procedures must be qualified and validated. Every NDA/ANDA inspection will include both an evaluation of laboratory controls and procedures and an audit of some of the raw data used to generate results. These data may be located in research and development test logs. The authenticity and accuracy of data used in the development of a test method should be established. (See the Guide to Inspection of Pharmaceutical Quality Control Laboratories, July 1993.)... [Pg.32]

See other pages where Laboratory equipment and procedures is mentioned: [Pg.7] [Pg.223] [Pg.253]